FDAFDA · Food and drugs·Recall number Z-1831-2013
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
Published August 7, 2013 · Recall initiated: April 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product fails to meet the accuracy at the low end of the measuring range.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wako Life Sciences, Inc.
- Distributor
- Distribution to CA, GA, MN, NC, UT and the District of Columbia.
- Lot
- TG340, Exp. 11/30/13
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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